Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2026-01-03 @ 11:26 AM
Study NCT ID:
NCT04513067
Status:
TERMINATED
Last Update Posted:
2023-12-08
First Post:
2020-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety Study of YQ23 in Advanced Solid Tumors Patients
Sponsor:
New Beta Innovation Limited
Organization:
Study Overview
Official Title:
A Phase Ib, Open-label, Dose-escalation Study of YQ23 as a Single Agent and in Combination With Pembrolizumab Administered to Patients With Advanced Solid Tumors
Status:
TERMINATED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to business decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an early phase dose escalation study which is divided into two stages: (1) Single agent of the test drug YQ23, and (2) in combination with pembrolizumab administered to patients with advanced solid tumors.
The purpose of the study is find out the safety and tolerability profile, as well as maximum tolerated dose (MTD) of YQ23 as single agent (stage 1) and in combination with pembrolizumab (stage 2). Stage 2 will start only when the MTD of single agent YQ23 has been established in Stage 1.
The distribution of YQ23 in the blood, the tumor response to YQ23 (and pembrolizumab in stage 2), the change of some pre-defined biomarkers in the tumor tissues and blood, and the change of antibody response and its relationship with the disease response, safety and drug level in the blood will also be evaluated.
In stage 1, eligible patients will be given intravenous infusion of YQ23 weekly for 6 weeks. In stage 2, eligible patients will be also be given a fixed dose of pembrolizumab 200 mg on Day 1 and every 3 weeks thereafter in addition to the weekly dose of YQ23. Dose escalation decision will be made based on the safety data available for the 6 weeks study treatment(s).
Patients may continue study treatment(s) beyond 6 weeks if s/he tolerates the study drug(s) well, the disease does not get worse after first 6 doses and meet all treatment continuation criteria, as judged by the study doctor.
The purpose of the study is find out the safety and tolerability profile, as well as maximum tolerated dose (MTD) of YQ23 as single agent (stage 1) and in combination with pembrolizumab (stage 2). Stage 2 will start only when the MTD of single agent YQ23 has been established in Stage 1.
The distribution of YQ23 in the blood, the tumor response to YQ23 (and pembrolizumab in stage 2), the change of some pre-defined biomarkers in the tumor tissues and blood, and the change of antibody response and its relationship with the disease response, safety and drug level in the blood will also be evaluated.
In stage 1, eligible patients will be given intravenous infusion of YQ23 weekly for 6 weeks. In stage 2, eligible patients will be also be given a fixed dose of pembrolizumab 200 mg on Day 1 and every 3 weeks thereafter in addition to the weekly dose of YQ23. Dose escalation decision will be made based on the safety data available for the 6 weeks study treatment(s).
Patients may continue study treatment(s) beyond 6 weeks if s/he tolerates the study drug(s) well, the disease does not get worse after first 6 doses and meet all treatment continuation criteria, as judged by the study doctor.
Detailed Description:
This is a phase 1b, open-label, dose-finding study to primarily evaluate the safety and tolerability, and MTD of YQ23 as a single agent and when in combination with pembrolizumab ("combo therapy") in patients with advanced malignant solid tumors of which it will have the potential to benefit from immunotherapy, such as triple negative breast cancer, colorectal cancer, liver cancer, non-small cell lung cancer, or renal cell carcinoma. In the study, the Pharmacokinetics (PK) profile and the disease response to YQ23 will be investigated while the Pharmacodynamics (PDx) profile and immunogenicity of YQ23 will be explored when YQ23 is given alone and in combo therapy.
The study composes of 2 stages. Stage 1 is a YQ23 alone dose escalation study; and Stage 2 is YQ23 in combination with pembrolizumab dose escalation study. The primary objective of the study is to establish the MTD of YQ23 as a single agent and the MTD when given in combination with pembrolizumab, by evaluating the incidence of dose-limiting toxicities (DLT).
In Stage 1, trial subjects will be enrolled successively in the treatment cohorts of 5 dose levels of YQ23. Each subject will receive an intravenous fixed dose of YQ23 weekly in one of the treatment cohorts. Stage 2 will start only when the MTD of single agent YQ23 has been established in Stage 1. In Stage 2, trial subjects will be enrolled successively in combo therapy dose cohorts starting with the lowest tested dose of YQ23 up to the MTD established in Stage 1. In each cohort of Stage 2, a fixed dose of 200 mg pembrolizumab will be given every 3 weeks on the same day following YQ23 administration.
Dose escalation decision will be made by an Independent Data Safety Monitoring Committee (DSMC) as determined by the DLT which is based on the incidence and intensity of drug-related adverse events (toxicities) occurring up to 5 days after the administration of the sixth dose of YQ23 in the single and combo therapy. The toxicities will be graded by the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) v5.0.
At least 3 evaluable subjects will be treated per dose cohort. Evaluable subjects are defined as subjects who have completed the first 6 doses of YQ23 and the safety assessment at Day 6 post YQ23 Dose 6, or subjects who have discontinued treatment due to a DLT. Dose escalation will only be started after all subjects in the previous cohort have completed assessments at Day 6 post Dose 6 of YQ23 in the single and combo therapy dose escalations. A satisfactory review of the safety and tolerability data by the DSMC is required before any dose escalation.
Following a 3+3 design, the MTD is defined as the highest dose level at which six patients are treated and one DLT has been observed, or three patients are treated and no one has experienced a DLT. If no DLT is found, the highest dose will be determined as the MTD.
The study composes of 2 stages. Stage 1 is a YQ23 alone dose escalation study; and Stage 2 is YQ23 in combination with pembrolizumab dose escalation study. The primary objective of the study is to establish the MTD of YQ23 as a single agent and the MTD when given in combination with pembrolizumab, by evaluating the incidence of dose-limiting toxicities (DLT).
In Stage 1, trial subjects will be enrolled successively in the treatment cohorts of 5 dose levels of YQ23. Each subject will receive an intravenous fixed dose of YQ23 weekly in one of the treatment cohorts. Stage 2 will start only when the MTD of single agent YQ23 has been established in Stage 1. In Stage 2, trial subjects will be enrolled successively in combo therapy dose cohorts starting with the lowest tested dose of YQ23 up to the MTD established in Stage 1. In each cohort of Stage 2, a fixed dose of 200 mg pembrolizumab will be given every 3 weeks on the same day following YQ23 administration.
Dose escalation decision will be made by an Independent Data Safety Monitoring Committee (DSMC) as determined by the DLT which is based on the incidence and intensity of drug-related adverse events (toxicities) occurring up to 5 days after the administration of the sixth dose of YQ23 in the single and combo therapy. The toxicities will be graded by the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) v5.0.
At least 3 evaluable subjects will be treated per dose cohort. Evaluable subjects are defined as subjects who have completed the first 6 doses of YQ23 and the safety assessment at Day 6 post YQ23 Dose 6, or subjects who have discontinued treatment due to a DLT. Dose escalation will only be started after all subjects in the previous cohort have completed assessments at Day 6 post Dose 6 of YQ23 in the single and combo therapy dose escalations. A satisfactory review of the safety and tolerability data by the DSMC is required before any dose escalation.
Following a 3+3 design, the MTD is defined as the highest dose level at which six patients are treated and one DLT has been observed, or three patients are treated and no one has experienced a DLT. If no DLT is found, the highest dose will be determined as the MTD.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: